Efficacy, safety and cost analyses in ulcerative colitis patients undergoing granulocyte and monocyte adsorption or receiving prednisolone

Abstract

BackgroundPatients with ulcerative colitis (UC) are treated with prednisolone (PSL), which causes adverse side effects. Extracorporeal granulocyte/monocyte adsorption (GMA) with an Adacolumn depletes elevated/activated myeloid lineage leucocytes as sources of inflammatory cytokines. We were interested to evaluate the efficacy, safety and the treatment cost for PSL and GMA.MethodsForty-one patients with active UC had achieved remission with GMA, at 1 or 2 sessions/week, up to 10 sessions (n=24) or with orally administered PSL (1mg/kg bodyweight, n=17). Clinical activity index (CAI) ≤4 was considered clinical remission. Following remission, patients received 5-aminosalicylic acid (2250-3000mg/day) or sulphasalazine (4000-6000mg/day) as maintenance therapy and were followed for 600 days. The total treatment cost was assessed based on 1€=150JPY.ResultsPSL was tapered after two weeks, and discontinued when a patient achieved remission. The average time to the disappearance of at least one major UC symptom (haematochezia, diarrhoea, or abdominal discomfort) was 15.3 days in the GMA group and 12.7 days in the PSL group, while time to remission was 27.9 days in the GMA group and 27.6 days in the PSL group, CAI 0.8 and 2.0, respectively. The Kaplan-Meier plots showed similar remission maintenance rates over the 600 days follow-up period. The average medical cost was 12739.4€/patient in the GMA group and 8751.3€ in the PSL group (P<0.05). In the GMA group, 5 transient adverse events were observed vs 10 steroid related adverse events in the PSL group (P<0.001).ConclusionsIn appropriately selected patients, GMA has significant efficacy with no safety concern. The higher cost of GMA vs PSL should be compromised by good safety profile of this non-pharmacological treatment intervention.

Adsorptive Granulocyte and Monocyte Apheresis in the Treatment of Ulcerative Colitis: The First Multicenter Study in China

“…The rate (8.82%) is much lower than the incidence seen in most patients on corticosteroids 3. Additionally, we found that common biochemical markers, including liver and kidney functions, were not affected by GMA.…”

“…Tominaga et al 3. undertook a comprehensive assessment of cost, efficacy, and safety for GMA vs prednisolone, a commonly used corticosteroid.…”

“…GMA is aimed at reducing the elevated and activated leucocytes known to be sources of inflammatory cytokines 1,3–21. In most hitherto studies, the efficacy outcomes have been promising.…”

Pharmacokinetic Evaluation of Chitosan-Succinyl-Prednisolone Conjugate Microparticles as a Colonic Delivery System: Comparison with Enteric-Coated Conjugate Microparticles

“…Prednisolone (PD) is often used for the treatment of IBD because it can function effectively and promptly even to the severe diseased states [8] [9]. However, as PD causes severe toxic side effect considerably in a prolonged use or high dose, its use is generally limited [10] [11].…”

Pharmacological- and non-pharmacological therapeutic approaches in inflammatory bowel disease in adults

“…Therefore Vecchi recommended in his review the perpetuation of the traditional treatment schedule of 5 sessions in 5 wk (1/wk) as it is seems not to be inferior to the more intensive version, more convenient to the patients and more cost effective [158] . Still more randomized sham controlled double blind trials with a long term surveillance to evaluate the long term outcome, treatment schedules and cost effectiveness (equipment, pharmacological therapy, avoidance of surgical intervention) are required, although several reports attest comparable costs to conventional therapy as the good safety profile should comprise higher costs [161] . According to current data the American Society for Apheresis (ASFA) assigned 2013 GMA in UC to category Ⅱ/Ⅲ with a recommendation level of Grade 1B/2B (strong to weak recommendation, moderate quality evidence) and the CD to category Ⅲ, recommendation 1B (strong, but randomized controlled trials with important limitations) [162] .…”